Luye Pharma’s Lurbinectedin for Metastatic SCLC Accepted for Review by China’s NMPA
China-based Luye Pharma Group (HKG: 2186) has announced that its market filing for lurbinectedin (LY01017)...
Market approval filings
Lee’s Pharmaceutical Subsidiary Zhaoke Ophthalmology Announces FDA Review of NVK002 for Pediatric Myopia
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced...
Legend Biotech Submits sBLA to Expand Carvykti Label for Relapsed Multiple Myeloma
Legend Biotech Corporation (NASDAQ: LEGN) has announced the submission of a supplemental Biologics License Application...
Novo Nordisk’s Semaglutide for Weight Loss Accepted for Review by China’s NMPA
Denmark-headquartered Novo Nordisk (NYSE: NVO) has announced that its market filing for the glucagon-like peptide-1...
Akeso Biopharma’s Ebronucimab NDA Accepted for Review by China’s NMPA
China-based Akeso Biopharma (HKG: 9926) has announced that the National Medical Products Administration (NMPA) has...
Takeda and HutchMed’s Fruquintinib Receives Priority Review Status from FDA
Takeda (TYO: 4502) and HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) have provided an update...
Sino Biopharmaceutical’s TQ-B3525 Files for Market Approval with CDE
Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1...
Shanghai Junshi Biosciences’ Tuoyi Combo for Triple Negative Breast Cancer Accepted for Review
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities...
Antengene Submits Market Approval Filing for Xpovio in Indonesia for Multiple Myeloma and Lymphoma
Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its...
Sichuan Kelun Pharmaceutical’s A166 Anti-HER2 ADC NDA Accepted for Review by NMPA
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has announced that the...
Grand Pharmaceutical Group Files NDA for Ophthalmic Analgesic APP13007 with US FDA
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the filing of a New Drug...
Jiangsu Hengrui’s Vunakizumab for Plaque Psoriasis Accepted for Review by NMPA
Jiangsu Hengrui Pharmaceutials Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, announced that the...
CSPC Pharmaceutical’s Prusogliptin for Type 2 Diabetes Accepted for NMPA Review
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading China-based pharmaceutical company, announced that its market...
Junshi Biosciences Submits Market Filings for PCSK9 mAb Ongericimab to NMPA
China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced the submission of two market filings...
HutchMed’s Elunate Receives NMPA Review for Second-Line Gastric Cancer Treatment
China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that the National Medical Products Administration (NMPA)...
Ocumension Therapeutics’ Zerviate NDA Accepted for Review by China’s NMPA
Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that the National Medical...
Shanghai Fosun Pharmaceutical Submits Market Approval Filing for Daxibotulinumtoxin A in China
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a market approval filing to...
Luye Pharma’s Bevacizumab Biosimilar Accepted for Review in Brazil by ANVISA
China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its...
FDA Issues Complete Response Letters to Six Novel Drugs in Q1 2023
According to an analysis, the US FDA issued complete response letters (CRLs) to six novel...
Everest Medicines’ Nefecon NDA Accepted for Review by Singapore’s HSA
China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore...